Cellectar Receives FDA Breakthrough Therapy Designation for Iopofosine I-131
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Cellectar Biosciences for its lead candidate, iopofosine I-131
This designation applies to the treatment of relapsed or refractory Waldenstrom’s macroglobulinemia (r/r WM), a rare and currently incurable form of lymphoplasmacytic lymphoma.
Iopofosine I 131 is a novel radioconjugate therapy that uses a phospholipid ether to deliver radioactive iodine directly to cancer cells.
The Breakthrough Therapy Designation is intended to speed up the development and review of treatments that show early clinical evidence of significant improvement over existing options for serious conditions.
Currently, treatment options for WM remain limited and are not curative. As recognised by leading disease foundations, there remains a strong need for therapies that work differently and can improve patient outcomes.
Iopofosine I 131 has also been granted Fast Track and Orphan Drug designations by the FDA. In Europe, the European Medicines Agency (EMA) has provided Orphan Drug and PRIME designations for the same indication.
Separately, Cellectar has submitted a data package to the EMA containing preclinical, regulatory, manufacturing, and clinical trial results from the CLOVER WaM study.
The submission will help determine if the company can move forward with a conditional marketing authorisation application.
Breakthrough Therapy Designation offers more frequent engagement with the FDA and may support a faster six-month priority review of a future New Drug Application.
